Catalog Number

-

Brand Name

Dialysis Priming Set

Version/Model Number

M4-9440

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

b7971279-633f-48e7-9032-13104d57efec

Public Version Date

October 14, 2020

Public Version Number

1

DI Record Publish Date

October 06, 2020

Package DI Number

10842289102610

Quantity per Package

200

Contains DI Package

00842289102613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box